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Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

Primary Purpose

Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Donepezil

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring cognitive/functional effects, neurotoxicity, long-term effects secondary to cancer therapy in children, psychosocial effects of cancer and its treatment, radiation toxicity, childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood craniopharyngioma, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, childhood spinal cord neoplasm, childhood brain stem glioma, childhood cerebellar astrocytoma, childhood medulloblastoma, childhood supratentorial primitive neuroectodermal tumor, childhood visual pathway and hypothalamic glioma, childhood subependymal giant cell astrocytoma, childhood ependymoma, childhood cerebral astrocytoma/malignant glioma

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Prior diagnosis of primary brain tumor
No type 2 neurofibromatosis
Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
Karnofsky or Lansky performance status 70-100%
Fertile patients willing to use effective contraception
Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
Stable weight within the past 6 months with no concern of weight loss
Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
Able to speak English
More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug

Exclusion Criteria:

Stereotactic radiosurgery as sole treatment
Evidence of disease progression by MRI
Pregnant or nursing
Attention-deficit/hyperactivity disorder before cancer diagnosis
Uncontrolled seizures or uncontrolled endocrinopathies
Uncontrolled comorbidities
Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
Use of concurrent anticholinergic drugs

Sites / Locations

Tufts-NEMC Cancer Center
Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Donepozil

Arm Description

Donepezil 5 milligrams a day for 6 weeks

Outcomes

Primary Outcome Measures

Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks

Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.

Secondary Outcome Measures

Full Information

NCT ID

NCT00452868

First Posted

March 27, 2007

Last Updated

August 8, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00452868

Brief Title

Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

Official Title

A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 2006 (Actual)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain. PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain.

Detailed Description

OBJECTIVES: Primary Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy. Secondary Assess health-related quality of life of patients treated with this drug. Assess function and quality of life of the families of patients treated with this drug. Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug. Determine the toxicity of donepezil hydrochloride in these patients. OUTLINE: This is a multicenter, pilot, open-label, controlled study. Patients receive oral donepezil hydrochloride once daily or once every other day for up to 24 weeks in the absence of disease progression or unacceptable toxicity. After completion of 6 weeks of study therapy, patients are evaluated for toxicity. Patients experiencing no adverse effects from treatment may continue receiving donepezil hydrochloride at a higher dose for 18 more weeks. Patients undergo measurement of cognitive function (by neurocognitive testing), behavioral adjustment and social competency (by parent-reported questionnaires), health-related quality of life (by child- and parent-reported questionnaires), and vascular dynamics (by transcranial Doppler ultrasound) at baseline and at weeks 12, 24, and 36. Family function and family quality of life are assessed at baseline and at week 24. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity

Keywords

cognitive/functional effects, neurotoxicity, long-term effects secondary to cancer therapy in children, psychosocial effects of cancer and its treatment, radiation toxicity, childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood craniopharyngioma, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, childhood spinal cord neoplasm, childhood brain stem glioma, childhood cerebellar astrocytoma, childhood medulloblastoma, childhood supratentorial primitive neuroectodermal tumor, childhood visual pathway and hypothalamic glioma, childhood subependymal giant cell astrocytoma, childhood ependymoma, childhood cerebral astrocytoma/malignant glioma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Donepozil

Arm Type

Experimental

Arm Description

Donepezil 5 milligrams a day for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Donepezil

Intervention Description

Donepezil 5 milligrams a day for 6 weeks

Primary Outcome Measure Information:

Title

Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks

Description

Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prior diagnosis of primary brain tumor No type 2 neurofibromatosis Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago Karnofsky or Lansky performance status 70-100% Fertile patients willing to use effective contraception Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3 Stable weight within the past 6 months with no concern of weight loss Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated Able to speak English More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug Exclusion Criteria: Stereotactic radiosurgery as sole treatment Evidence of disease progression by MRI Pregnant or nursing Attention-deficit/hyperactivity disorder before cancer diagnosis Uncontrolled seizures or uncontrolled endocrinopathies Uncontrolled comorbidities Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent) Use of concurrent anticholinergic drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon M. Castellino, MD, FAAP

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Tufts-NEMC Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Wake Forest University Comprehensive Cancer Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157-1096

Country

United States

12. IPD Sharing Statement

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Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

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